Innoviva, Inc. (NASDAQ:INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application (NDA) for sulbactam-durlobactam (SUL-DUR).
SUL-DUR is an investigational targeted antibiotic for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortalityi. Carbapenem-resistant Acinetobacter is considered an urgent public health threat by the Centers for Disease Control and Prevention (CDC)ii and a Priority 1 pathogen by the World Health Organization (WHO)iii.
The Committee will review data from studies involving SUL-DUR, including data from the landmark Phase 3 trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter. In the trial, SUL-DUR demonstrated statistical non-inferiority versus colistin for the primary end point of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates. SUL-DUR also exhibited a favorable safety profile with lower incidence of nephrotoxicity compared to colistin.
The SUL-DUR NDA, filed on September 29, 2022 by Entasis Therapeutics Inc., a wholly owned subsidiary of Innoviva, is currently under Priority Review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.